Therapeutic Focus

Acute Pain Management

Millions of Patients Suffer from Acute Pain

There are about 46 million inpatient and 53 million outpatient surgeries performed in the United States each year that require drugs for postoperative pain, and over half of these patients still experience inadequate pain relief.

For acute postoperative pain management, the existing therapeutic classes are traditional centrally-acting mu opioid analgesics (morphine, fentanyl, hydromorphone) and non-steroidal anti-inflammatory drugs (NSAIDs) as well as acetaminophen. This market is dominated by injectable formulations of opioids (e.g., morphine and fentanyl) for the intravenous, intramuscular, intrathecal, or epidural routes of administration, directly by hospital personnel or with patient-controlled analgesia (PCA) devices.

The market for acute pain managed outside the hospital setting in the United States exceeds 200 million prescriptions dispensed annually. This market is comprised of primarily oral centrally-acting immediate release mu opioid analgesic combinations (e.g. Vicodin®, Percocet®). These products, although effective for acute pain management, have significant mu-opioid side effects (dizziness, sedation, nausea/vomiting, respiratory depression, euphoria and abuse). Since these side effects are quite common, there is a tremendous opportunity for a novel analgesic that is effective in managing acute pain without producing these mu-opioid side effects.

Randomized trials have shown that multimodal anesthesia involving simultaneous use of combinations of several medications -- acting on different pain receptors or administered through different techniques -- are associated with superior pain relief and decreased opioid consumption compared with use of a single medication administered by one technique.

Roger Chou, MD
Co-author of the proposed opioid prescribing guidelines developed by Centers for Disease Control and Prevention

The Need for a Truly Novel Analgesic for Acute Pain

Despite the fact that there are literally hundreds of medicines for acute pain management, many patients still experience inadequate pain relief as well as significant side effects with their medications. Non opioid pain medication like NSAIDs (e.g. ibuprofen) and acetaminophen frequently don’t provide enough pain relief and sometimes produce significant side effects like gastrointestinal bleeding, cardiovascular issues (NSAIDs) or hepatotoxicity (acetaminophen).

Centrally-acting mu opioids (e.g. morphine, oxycodone, hydrocodone), the mainstay of acute pain management both inside and outside the hospital setting, also have significant issues. In the hospital setting, mu opioids produce significant side effects like nausea/vomiting and respiratory depression (slow or stopped breathing) that can lead to an increase in length of hospital stay and cost per patient by as much as 69% and 56% respectively. Outside the hospital setting, the increase in mu opioid usage has triggered an opioid abuse epidemic in the United States with nearly 19,000 people dying from mu opioid overdose in 2014 alone.

The patients who experience acute pain and the clinicians who treat it are desperately in need of a new novel analgesic that will work differently than mu opioid, NSAID or acetaminophen, yet provide pain relief without the significant side effects you find in yesterday’s and today’s medicines.